telmisartan and amlodipine

Generic: telmisartan and amlodipine

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name telmisartan and amlodipine
Generic Name telmisartan and amlodipine
Labeler lupin pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amlodipine besylate 10 mg/1, telmisartan 40 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-197
Product ID 68180-197_17a6182b-5050-470e-aa1d-1605fa9e088e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201586
Listing Expiration 2026-12-31
Marketing Start 2014-01-08

Pharmacologic Class

Established (EPC)
angiotensin 2 receptor blocker [epc]
Mechanism of Action
angiotensin 2 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180197
Hyphenated Format 68180-197

Supplemental Identifiers

RxCUI
876514 876519 876524 876529
UPC
0368180196068
UNII
864V2Q084H U5SYW473RQ
NUI
N0000000070 N0000175561

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name telmisartan and amlodipine (source: ndc)
Generic Name telmisartan and amlodipine (source: ndc)
Application Number ANDA201586 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
  • 40 mg/1
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING Telmisartan and amlodipine tablets USP are available as 40 mg/5 mg Oval shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have yellow specks, debossed with 'C54' and Telmisartan layer is yellow in colour but may have white specks, debossed with 'LU'. 40 mg/10 mg Oval shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have red specks, debossed with 'C55' and Telmisartan layer is red in colour but may have white specks, debossed with 'LU'. 80 mg/5 mg Capsule shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have red specks, debossed with 'C56' and Telmisartan layer is red in colour but may have white specks, debossed with 'LU'. 80 mg/10 mg Capsule shaped, biconvex, bilayer, uncoated tablet where Amlodipine layer is white but may have yellow specks, debossed with 'C57' and Telmisartan layer is yellow in colour but may have white specks, debossed with 'LU'. Telmisartan and amlodipine tablets USP are supplied for oral administration in the following strengths and package configurations: Tablet strength ( telmisartan / amlodipine besylate equivalent to amlodipine ) mg Package Configuration NDC # 40 mg/5 mg Bottles of 30 Bottles of 90 A box containing 100 Tablets (10 X 10 unit-dose) 68180-196-06 68180-196-09 68180-196-13 40 mg/10 mg Bottles of 30 Bottles of 90 A box containing 100 Tablets (10 X 10 unit-dose) 68180-197-06 68180-197-09 68180-197-13 80 mg/5 mg Bottles of 30 Bottles of 90 A box containing 100 Tablets (10 X 10 unit-dose) 68180-198-06 68180-198-09 68180-198-13 80 mg/10 mg Bottles of 30 Bottles of 90 A box containing 100 Tablets (10 X 10 unit-dose) 68180-199-06 68180-199-09 68180-199-13 Storage Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Do not remove from blisters until immediately before administration. Protect from moisture and light.
  • PRINCIPAL DISPLAY PANEL TELMISARTAN AND AMLODIPINE TABLETS Rx Only 40 mg/5 mg NDC 68180-196-06 A Bottle of 30 tablets TELMISARTAN AND AMLODIPINE TABLETS Rx Only 40 mg/10 mg NDC 68180-197-06 A Bottle of 30 tablets TELMISARTAN AND AMLODIPINE TABLETS Rx Only 80 mg/5 mg NDC 68180-198-06 A Bottle of 30 tablets TELMISARTAN AND AMLODIPINE TABLETS Rx Only 80 mg/10 mg NDC 68180-199-06 A Bottle of 30 tablets p 2 c g
source: label

Packages (0)

No package records.

Ingredients (2)

amlodipine besylate (10 mg/1) telmisartan (40 mg/1)

Linked Drug Pages (1)

Telmisartan and Amlodipine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "17a6182b-5050-470e-aa1d-1605fa9e088e", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0368180196068"], "unii": ["864V2Q084H", "U5SYW473RQ"], "rxcui": ["876514", "876519", "876524", "876529"], "spl_set_id": ["a97fefa6-99e6-4eb7-9393-ab2252a2c7d8"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Telmisartan and Amlodipine", "product_id": "68180-197_17a6182b-5050-470e-aa1d-1605fa9e088e", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]", "Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A Inhibitors [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "68180-197", "generic_name": "Telmisartan and Amlodipine", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Telmisartan and Amlodipine", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "10 mg/1"}, {"name": "TELMISARTAN", "strength": "40 mg/1"}], "application_number": "ANDA201586", "marketing_category": "ANDA", "marketing_start_date": "20140108", "listing_expiration_date": "20261231"}